We are delighted about the opportunity to participate in the European Medicines Agency’s (EMA) PMS Information Day in June 2026, which gave us the chance to learn about and discuss the latest developments with other experts from all over Europe. Here we summarize some of the most important results of this special event.
The EMA is moving away from document-heavy workflows toward data-driven regulation. PMS will serve here as a shared “source of truth,” which allows for entering data once and reusing it across multiple regulatory processes. This supports shortages monitoring, pharmacovigilance, variation simplification, and cross-border healthcare.
More and more life science organizations consider data quality a core business responsibility now, and this is more essential than ever: Organizations must adopt continuous data management instead of periodic submissions, ensuring that their information stays accurate and aligned across EMA, NCAs, and industry.
We need to consider API-driven integration as the coming standard way to interact with regulators for companies. Together with machine-to-machine communication, it is a core enabler of PMS.
The transition to PMS will follow a stepwise path:
Gradual phase-out of XEVMPD
Support for both PMS and XEVMPD during the transition phase
PMS becomes the main submission channel by 2029
Invest early in data governance and quality frameworks
Prioritize API-readiness and scalable integration
Align internal data models with PMS and IDMP standards
Train teams to work on data-driven workflows
Avoid heavy investment in XEVMPD-specific enhancements
The EMA has set clear deadlines for MAHs:
By the end of June 2026: Complete submission of manufacturers and structured package details for non-CAPs in the ULCM list
By the end of December 2026: Complete submission of manufacturers for all other non-CAPs
By the end of June 2027: Submit package sizes and structured package details for all other non-CAPs
The EMA emphasized that collaboration between regulators, NCAs, industry, and technology partners is essential. Working together will unlock the benefits of PMS and create a unified, high-quality, and future-proof data ecosystem for medicinal products in Europe.